MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 AXIUM PRIME; DEVICE, EMBOLIZATION, VASCULAR

Model Number	APB-3-6-HX-ES
Medical Device Problem Codes	Break (1069); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/24/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received a report that, after pushing a small distance, there was large resistance between the microcatheter and coil.The issue persisted despite multiple attempts.It was noticed that the coil was damaged, and that the pusher was kinked/broken.As a result the device was replaced.The patient was undergoing surgery for treatment of a ruptured, amorphous aneurysm with a max diameter of 4.5mm and a neck diameter of 3.8mm.It was noted that the blood flow and vessel tortuosity were normal.There were no related patient symptoms.The devices were prepared as indicated per the ifu.A continuous flush was used.Ancillary devices include a navien 6f 115cm.
Additional Manufacturer Narrative
The axium prime coil was returned within a dispenser coil and within an introducer sheath.The implant coil was partially pushed out of the introducer sheath.The axium prime coil was decontaminated.The introducer sheath was found correctly assembled on the pushwire with the wavelock at the proximal end.No damages or irregularities were found with the introducer sheath.The axium prime pushwire was found to be bent within the introducer sheath and kinked within the introducer sheath.The axium prime implant coil was found broken off the detach element with the polypropylene filament also broken.The detached implant coil was found stretched and damaged.All other subassemblies appeared to be normal and no other anomalies were observed.Based on the device analysis and reported information, the report of ¿pusher kink/broke¿ was confirmed.It is likely the cause of the bent/kinked pushwire was due to advancing the coil against the reported high resistance.The implant coil was found damaged, stretched and broken.It is likely that the damage to the axium prime implant coil occurred during the attempt to push/pull the coil through the micro catheter against the reported resistance, and during the reported multiple readjustments.Other possible causes are: lack of hydration before procedure, user does not maintain continuous flush, tortuous anatomy, coil is not retracted in a one-to-one motion with the implant pusher during repositioning, pushwire rotation, or incompatible catheter.As customer reported no issue with pushing out the implant coil during hydration.It is also possible the implant coil became damaged when retracting the implant coil following hydration or due to improper hubbing technique (overtightening of the rhv or the introducer sheath was not fully seated in the hub).The customer report of ¿coil resistance/stuck in catheter¿ could not be confirmed and the root cause could not be determined.The axium prime coil could not be used for resistance testing with an in-house micro catheter due to its damaged condition.Possible causes for coil resistance in catheter are, but not limited to, use of an incompatible device for delivery, severely tortu ous patient anatomy, failure to hydrate the axium prime coil prior to use, damage or kink to pushwire and lack of continuous flush during delivery.Since the micro catheter used in the event was not returned, and the model or lot number was not provided, any contribution of the micro catheter towards the ¿coil resistance/stuck in catheter¿ and ¿pusher kink/broke¿ could not be assessed.There is no indication that the event is related to a manufacturing issue, therefore a dhr review is not required.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• Brand Name: AXIUM PRIME
• Common Device Name: DEVICE, EMBOLIZATION, VASCULAR
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• MDR Report Key: 8839291
• Report Number: 2029214-2019-00790
• Device Sequence Number: 11448671
• Product Code: KRD
• UDI-Device Identifier: 00847536021082
• UDI-Public: 00847536021082
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K081465
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/12/2021
• Device Model Number: APB-3-6-HX-ES
• Device Catalogue Number: APB-3-6-HX-ES
• Device Lot Number: A739714
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/22/2019
• Initial Date Received by Manufacturer: 07/24/2019
• Supplement Date Received by Manufacturer: 09/26/2019
• Initial Report FDA Received Date: 07/29/2019
• Supplement Report FDA Received Date: 10/21/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 65 YR